03-7578. Submission for OMB Review, Comment Request; Organochlorine Exposure in Relation to Timing of Natural Menopause: The North Carolina Menopause Study

SUMMARY:

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on October 23, 2002, pages 65132-65133 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.

Proposed Collection:

Title: Organochlorine Exposure in Relation to Timing of Natural menopause (The North Carolina Menopause Study) Type of Information Collection Request: New. Need and Use of Information Collection: Smoking has been shown in many studies to be associated with a 1-2 year decrease in age at natural menopause. However, relatively little is known about the effect of other potential toxicants, including organochlorines such as polychlorinated biphenyls (PCBs), and 1,1 dichloro-2,2-bis(p-chlorophenyl) ethylene (p,p′-DDE (DDE). We will assess timing of menopause among women who previously participated in the North Carolina Infant Feeding Study. PCB and DDE levels were analyzed in blood and breast milk samples around delivery and after pregnancy. The median age of the women as of March 2002 is 50 years. Data will be collected in a telephone interview focusing on reproductibve and menstrual history with additional information collected on demographic, social and behavioral factors that could affecting time of menopause. Approximately 50% of participants based on sampling strata that involve criteria relating to age and menopausal status will also have a blood sample collection. The purpose of this study is to assess the association between the baseline organochlorine measurements and timing of natural menopause. A secondary aim will be to conduct exploratory analyses of the association between specific factors (e.g., pregnancy history, weight change) and rate of change in organochlorine levels. Frequency of Response: 1.1 responses per respondent. There also will be a yearly assessment of menopausal status based on a short interview (fifteen minute telephone interview) targeting women who are pre-menopausal based on the initial interview. Affected Public: Individuals or households. Types of Respondents: Women who participated in the North Carolina Infant Feeding Study. The annual reporting burden is as follows: Estimated Number of Respondents: 642 Estimated Number of Responses per Respondent: 1.1. Average Burden Hours Per Response: 0.66. Estimated Total Burden Hours Requested: 426. Annualized cost to respondents is $6,816. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Request for Comments:

Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Direct Comments to OMB:

Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Glinda Cooper, Epidemiology Branch, NIEHS, Building 101, A3-05, P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free number [phone] or E-mail your request, including your address to: “[e-mail]”.

Comments Due Date:

Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

Dated: March 20, 2003.

Francine Little,

NIEHS, Associate Director for Management.